BYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCED HYGIENICS LLC]

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BYOTROL HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [ADVANCED HYGIENICS LLC]
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NDC 63002-002-12, 63002-002-50, 63002-002-75, 63002-002-99
Set ID 09edbc17-c443-4b0d-9c28-c4b8233c4d1a
Category HUMAN OTC DRUG LABEL
Packager Advanced Hygienics LLC
Generic Name
Product Class
Product Number
Application Number PART333A
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  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    For hand sanitizing to decrease bacteria on the skin.

    Recommended for repeated use.

  • WARNINGS

    Warnings

    For external use only.

    When using this product avoid contact with eyes.

    In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Pump a small amount of foam onto hands.

    Rub thoroughly over all surfaces of both hands.

    Rub hands together briskly until dry.

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Dimethicone, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid.

  • QUESTIONS

    Questions? 1-866-443-4509

  • PRINCIPAL DISPLAY PANEL

    byotrol

    ANTIBACTERIAL FOAMING

    HAND SANITIZER

    ALCOHOL FREE  KILLS GERMS

    POWERFUL

    LONG LASTING

    GENTLE

    Net Contents: 16.9 FL OZ (500mL)

    container label

  • INGREDIENTS AND APPEARANCE
    BYOTROL HAND SANITIZER  
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63002-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    C12-15 PARETH-7 (UNII: 3XY03A79QH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63002-002-9950 mL in 1 BOTTLE; Type 0: Not a Combination Product05/02/2014
    2NDC:63002-002-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2014
    3NDC:63002-002-121250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2014
    4NDC:63002-002-759463 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/02/2014
    Labeler - Advanced Hygienics LLC (065359009)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wisconsin Pharmacal Company800873986manufacture(63002-002)
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